The prosthetic machine
The CNC® prosthesis is a licensed (ISO 9001–14000–18000) medical machine produced by a patented course of by Advihair srl. Briefly, a polymer, manufactured in-house by a proprietary technique, is formed on the mildew of the affected person’s head and coloured with a biologic pigment in line with her scalp pores and skin coloration. Natural untreated hair with the options of the affected person’s hair is utilized by hand on the molded polymer. Specialized personnel match the machine to the pinnacle and repair it with an adhesive substance; a patch take a look at guidelines out doable intolerance. The machine wants sanitization as soon as a month. A complete of 21 units have been donated by Cesare Ragazzi Laboratories (Italy) to carry out this research.
Patients enrolled within the research have been supplied with a personalised machine. They wore it so long as desired and so they have been allowed to take away the machine when happy with the size of hair. Application started earlier than alopecia was induced by chemotherapy.
Participants
Enrollment was carried out from October 2017 to July 2020 throughout the Complex Structure of Medical Oncology 1 of Fondazione IRCCS Istituto Nazionale dei Tumori of Milan. Patients with recurrent breast most cancers and CIA, and assembly the next inclusion standards have been enrolled: use of a conventional wig within the earlier expertise of CIA, age > 18 years, absence of cognitive problems, nervousness and/or despair, and willingness to use the proposed machine. A psychologist [AP] defined the research goals and procedures to the sufferers. Thereafter, if keen to make use of the prosthetic system and take part within the research, they signed a written consent type.
The affected person pattern was restricted to 21 topics as a result of variety of out there units.
Endpoints
The main endpoint was to judge the affect of sporting the CNC® prosthetic system in sufferers with a relapse of breast most cancers with CIA on physique picture and psychological well-being. The secondary endpoints included satisfaction, strengths and weaknesses of the machine. Both endpoints have been in contrast with the earlier use of a “conventional wig.”
Assessment
A mixed-method strategy [14] which features a survey and a spotlight group was used to attain analysis goals.
Survey A questionnaire was administered to all individuals.
The Italian validated model of the Body Image Scale (BIS) was used to judge the notion of physique picture [15, 16]. This 10-item scale investigates affective, behavioral, and cognitive dimensions of physique picture in sufferers affected with neoplasia. The complete rating ranged from 0 to 30: zero scores symbolize no signs or misery; increased scores correspond to growing signs and misery or extra physique picture issues.
The psychological well-being was assessed by the Italian model of the Psychological Well-Being Scale (PWB) [17, 18]. Answers are given on a 6-point Likert scale, and 18 gadgets are thought of. This questionnaire investigates six dimensions: autonomy, relationships, mastery of the atmosphere, private improvement, acceptance of oneself and objective in life. Each dimension ranged from 3 to 18: the upper the rating, the upper the psychological well-being.
The notion of hair was evaluated by two extra gadgets (“Hair is important to me” and “Hair is an important aspect of my look”) regarding how essential hair is to the affected person and the affect on bodily look. Each reply is given on a 5-point Likert scale, and the ensuing rating was thought of their common: the upper the rating, the upper the significance of hair.
Sociodemographic and medical information of sufferers have been collected. Occurrence of any discomfort with the machine was additionally recorded.
The starting of a brand new routine of chemotherapy was the baseline. At this time, sufferers have been required to reply the BIS by referring to their earlier expertise with a standard wig, whereas the PWB investigated their present well-being. Assessments have been repeated 3 and 6 months after making use of the machine, asking the affected person to judge the latest expertise with each BIS and PWB.
Focus group The first 12 sufferers who accomplished the usage of the machine have been requested to take part within the focus group. A spotlight group is a qualitative analysis approach used to deepen a theme by way of group interplay of people that have a typical expertise or attribute [19]. A psychologist with expertise in qualitative analysis [SA] facilitated the main target group. A semi-structured interview was used for the dialogue, and the interviewer used a non-directive modality. The following subjects have been thought of: baseline expectations concerning the machine, comparability of normal wigs with the CNC® machine, notion and analysis of the machine, doable weaknesses and willingness to purchase the machine.
Statistical evaluation
The scores of the notion of hair, BIS and PWB scales have been calculated in line with the developer’s indications. Descriptive statistics have been utilized to acquire abstract outcomes for every rating by time level.
Nonparametric rank-based fashions for longitudinal information have been used to mannequin the time tendencies for every scale [20, 21]. Those fashions are appropriate for non-Gaussian-distributed variables, are strong to outliers, and exhibit aggressive efficiency for small pattern sizes. These fashions enable to statistically take a look at the null speculation of no time impact utilizing an ANOVA-type take a look at [22, 23]. As extra evaluation when ANOVA-type take a look at was important, the Wilcoxon–Mann–Whitney actual paired take a look at adjusted for tied values was used to match distributions of scores at baseline versus 3 months and baseline versus 6 months [24].
The statistical significance degree of assessments was 0.05. Analysis was carried out in R [25].
Cronbach alpha values have been calculated at baseline (full information), with Bootstrap 95% CI with 2000 replications.
Qualitative evaluation
The focus group was audio-recorded, and transcriptions have been analyzed by way of a paper–pencil thematic evaluation [26]. Thematic evaluation is without doubt one of the hottest technique of analyzing qualitative information. With the phrase “theme” we referred to a subject or idea that emerges all through the textual content and that reply to the analysis goals. The themes might be articulated into sub-themes, every of them centered on particular points. The qualitative research adopted the Consolidated standards for reporting qualitative analysis (COREQ) [27].
